Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-24 @ 2:59 PM
NCT ID:
NCT02733159
Eligibility Criteria:
Core Inclusion Criteria:
* Histologically confirmed PD-L1 status defined NSCLC. Biopsy must be within 70 days of first treatment with pembrolizumab.
* Eastern Cooperative Oncology Group (ECOG) performance status 2.
* Life expectancy \> 12 weeks.
* Uni-dimensionally measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
* Computerised Tomography (CT) scan of chest and abdomen within 28 days of starting pembrolizumab.
* Adequate haematological function:
* Platelet count ≥100 x 109 /L.
* Neutrophils ≥1.5 x 109/L.
* Haemoglobin ≥ 90 g/L.
* Adequate hepatic function:
* Serum bilirubin ≤1.5 x upper limit of normal (ULN).
* Serum transaminases ≤2.5 x ULN.
* Adequate renal function: Creatinine clearance \<1.5 times ULN concurrent with creatinine clearance \>50 ml/min.
* Provision of signed and dated, written informed consent prior to any trial specific procedures, sampling and analyses.
Core Exclusion Criteria:
* Patients who do not meet the criteria of performance status = 2 on the ECOG Performance scale.
* Untreated symptomatic brain or leptomeningeal metastatic disease.
* Medical or psychiatric conditions compromising informed consent.
* Any medical condition which in the opinion of the investigator would compromise the ability of the patient to participate in the trial or which would jeopardise compliance with the protocol.
* Radiotherapy within 28 days of trial treatment.
* Active autoimmune disease that has required systemic treatment in past 2 years
* Chronic usage of steroids or other immunosuppressant medication.
* Previous history of pneumonitis.
* Any evidence of clinical autoimmunity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02733159
Study Brief:
Protocol Section:
NCT02733159